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Completed

NCT Number: NCT04935775

The Effect of Touch on Pain and Anxiety During the Bone Marrow Biopsy Procedure

This study is analyzing the benefit of untrained touch provided during a bone marrow biopsy procedure as compared to performing the procedure without providing it.

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Key information

Conditions

Pain, Acute Acute Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth Hitchcock Medical Center, Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

About this study

Two protocol-identified licensed nursing aides (LNA) will provide an unstructured simple touch intervention that requires no special training other than being oriented to "rub patient's feet" during the procedure. Data will be collected through patient-reported outcomes to determine if "untrained" touch has therapeutic results in managing a patient's pain and anxiety during a bone marrow biopsy procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients from Norris Cotton Cancer Center who have been scheduled for a bone marrow biopsy at the Outpatient Surgical Center at Dartmouth-Hitchcock Medical Center.
  • Subjects must be able to read and write in English to provide informed consent and fill out the questionnaires.

Exclusion criteria

  • Patients who do not wish to have their feet and lower legs touched during the procedure
  • Open sores on their feet or lower legs.

Treatment and study plan

Untrained Touch

Other

Subject's feet, ankles, and lower legs are touched and rubbed during a bone marrow biopsy procedure.

Primary outcomes

  1. Evaluate patient-reported pain levels

    Time frame: During the study procedure

    Patients be asked to describe what their pain level was before, at its worst point during the procedure and after the bone marrow biopsy. The Visual Analog Scale (VAS) will be used on a 0 to 10 scale, 0 being no pain at all and 10 being the worst pain imaginable.

  2. Evaluate patient-reported anxiety levels

    Time frame: During the study procedure

    The six -item short form Spiellberger State-Trait Anxiety Inventory (STAI), a self-reported questionnaire, will be administered on pencil and paper. Possible ranges of scores on the 6-item questionnaires vary from 6 to 24, with separate scores for both the state and trait anxiety sections. Answers to each question range from 1 to 4, 1 being no anxiety at all to 4 being very high anxiety (Julian, 2014). Patients will complete the short-form STAI before and after the procedure.

  3. Identify correlation between demographics and interventional response

    Time frame: During the study procedure

    Secondary endpoints will include identifying any correlation between demographic data collected and response to the intervention. The patient experience will be evaluated by using a visual analog scale at the completion of the procedure via paper and pencil that the subjects will complete independently. These open ended questions will be used to inform larger study questions in the future. Abstracted and deidentified summaries of responses will be prepared by the study PI.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Acronym: Dixon Project

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2021
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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